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High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
esterified estrogens
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Metastatic disease Documented disease progression Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer Disease progression during adjuvant tamoxifen is considered 1 prior therapy The 2 most recent treatments must have been endocrine agents At least 1 objective measurable disease parameter Brain metastases allowed provided both of the following criteria are met: Brain metastases were previously treated AND are currently stable Brain metastases are not the only site of metastatic disease Hormone receptor status Estrogen and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal, as defined by any of the following: At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range Under 50 years of age and FSH level within postmenopausal range Prior bilateral oophorectomy Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic Adequate hematologic function Hepatic Adequate hepatic function Bilirubin ≤ 1.5 times upper limit of normal No history of hepatic adenoma Renal Adequate renal function No history of hypercalcemia or severe hypocalcemia Cardiovascular No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use No active thrombophlebitis or thromboembolic disorders No history of uncontrolled hypertension Other Not pregnant No undiagnosed abnormal vaginal bleeding No other serious medical illness No psychiatric illness that would preclude giving informed consent No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Prior chemotherapy for metastatic disease allowed Prior adjuvant chemotherapy allowed Endocrine therapy See Disease Characteristics Radiotherapy Prior radiotherapy allowed provided the only site of measurable disease was not irradiated Surgery Not specified

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Outcomes

Primary Outcome Measures

Clinical response rate

Secondary Outcome Measures

Time to disease progression
Toxicity

Full Information

First Posted
August 16, 2005
Last Updated
June 7, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00131924
Brief Title
High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
Official Title
Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Data Monitoring Committee recommended closure due to poor accrual.
Study Start Date
March 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy. PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.
Detailed Description
OBJECTIVES: Primary Determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (Menest^®). Secondary Determine time to disease progression in patients treated with this drug. Determine the toxic effects of this drug in these patients. OUTLINE: Patients receive oral high-dose esterified estrogens (Menest^®) 3 times daily. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 2 months. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
recurrent breast cancer, stage IV breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
esterified estrogens
Primary Outcome Measure Information:
Title
Clinical response rate
Secondary Outcome Measure Information:
Title
Time to disease progression
Title
Toxicity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Metastatic disease Documented disease progression Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer Disease progression during adjuvant tamoxifen is considered 1 prior therapy The 2 most recent treatments must have been endocrine agents At least 1 objective measurable disease parameter Brain metastases allowed provided both of the following criteria are met: Brain metastases were previously treated AND are currently stable Brain metastases are not the only site of metastatic disease Hormone receptor status Estrogen and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal, as defined by any of the following: At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range Under 50 years of age and FSH level within postmenopausal range Prior bilateral oophorectomy Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic Adequate hematologic function Hepatic Adequate hepatic function Bilirubin ≤ 1.5 times upper limit of normal No history of hepatic adenoma Renal Adequate renal function No history of hypercalcemia or severe hypocalcemia Cardiovascular No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use No active thrombophlebitis or thromboembolic disorders No history of uncontrolled hypertension Other Not pregnant No undiagnosed abnormal vaginal bleeding No other serious medical illness No psychiatric illness that would preclude giving informed consent No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Prior chemotherapy for metastatic disease allowed Prior adjuvant chemotherapy allowed Endocrine therapy See Disease Characteristics Radiotherapy Prior radiotherapy allowed provided the only site of measurable disease was not irradiated Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J. Gradishar, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States

12. IPD Sharing Statement

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High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy

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